MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ATELLICA IM SARS-COV-2 IGG (SCOVG); SARS-COV-2 IMMUNOASSAY

Model Number N/A

Device Problem False Negative Result (1225)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/22/2022

Event Type  malfunction  

Manufacturer Narrative

An outside of the united states (ous) customer contacted the siemens customer care center to report an observation of a false negative (non-reactive) atellica im sars-cov-2 igg (scovg) result.The limitations section of the instructions for use state: "the performance of this test was established based on the evaluation of a limited number of clinical specimens collected from the united states and (b)(6) prior to 2019 and between (b)(6) 2020 to (b)(6) 2020.Additional 50 clinical specimens were collected from the united states between (b)(6) 2020 to (b)(6) 2020.The clinical performance has not been established in all circulating variants, but is anticipated to be reflective of the prevalent variants in circulation at the time and location of the clinical evaluation.Performance at the time of testing may vary depending on the variants circulating, including newly emerging strains of sars-cov-2 and their prevalence, which change over time." *a negative result for an individual subject indicates absence of detectable anti-sars-cov-2 antibodies.Negative results do not preclude sars-cov-2 infection and should not be used as the sole basis for patient management decisions.The sensitivity of this assay early after infection is unknown." a negative result can occur if the quantity of the anti-sars-cov-2 antibodies present in the specimen is below the detection limits of the assay, or the antibodies that are detected are not present during the stage of disease in which a sample is collected." *results are not intended to be used as the sole basis for patient management decisions.Test results should be interpreted in conjunction with clinical observations, patient history, epidemiological information, and other laboratory findings." a false negative/non-reactive result would be correlated with clinical history and presentation and may lead to additional testing and/or continued precautions to avoid infection with negligible clinical impact.Although there is no potential for serious injury in this case, an mdr will be reported to the fda as a requirement of the emergency use authorization (eua).Siemens is investigating.

Event Description

A customer obtained a non-reactive (negative) patient result with atellica im sars-cov-2 igg (scovg) lot 012.The result was considered discordant when compared to an alternate test method.The patient sample was tested as part of a study at the customer site and was not reported to physician(s).There are no known reports of patient intervention or adverse health consequences due to the false negative scovg result.

Manufacturer Narrative

Siemens filed mdr 1219913-2022-00077 initial report on 2022-03-25.Additional information - 2022-04-12.Siemens has completed the investigation into a false non-reactive (negative) patient result with atellica im sars-cov-2 igg (scovg) lot 012 compared to the reactive result of an alternate test method.Additionally, two other samples were also tested where clinical interpretation did not change, but the results did not quantitatively correlate between atellica and the alternate method.The customer was specifically looking to assess samples for omicron variant.There was no pcr testing provided to verify these were truly omicron positive patients, but the customer indicated that the samples were 28 days post positive covid swab test.The samples are not available to be retested.Atellica im scovg lot 012 has expired and no further testing can be performed.No further data is available.Siemens has previously tested omicron specific samples and the atellica im has been successful at detecting this variant.Siemens is unable to determine root cause of discrepancy.No product non-conformance has been identified.In section h6, investigation finding and investigation conclusion codes were updated based on the investigation results.

• Brand Name: ATELLICA IM SARS-COV-2 IGG (SCOVG)
• Type of Device: SARS-COV-2 IMMUNOASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591 5097
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 333 coney street; east walpole MA 02032
• Manufacturer Contact: stacy loukos ; 333 coney street; east walpole, MA 02032
• MDR Report Key: 13913526
• MDR Text Key: 288040435
• Report Number: 1219913-2022-00077
• Device Sequence Number: 1
• Product Code: QKO
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: EUA202669
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/17/2022
• Device Model Number: N/A
• Device Catalogue Number: 11207386
• Device Lot Number: 012
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/28/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1